200+ applicants

Company

Designs for Health · 15 hours ago

Senior VP of Quality Assurance & Regulatory Affairs

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$200K/yr - $250K/yr

15+ years exp

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Dietary SupplementsE-Commerce

Comp. & Benefits

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Responsibilities

Oversees the development and execution of the Quality and Regulatory strategy in alignment with company strategy and Objectives & Key Results (OKRs) and core KPIs.

Leads the Quality/EHS and Regulatory functions and teams, fostering a culture of quality, compliance, safety, excellence, accountability, and continuous improvement.

Creates and implements a roadmap for a world-class Quality function; ensures Quality and Safety metrics are aligned to the plan.

Ensures proper integration between Quality and Regulatory strategy plans, OKRs and KPIs for effective cross-functional collaboration and synergies across the teams.

Focuses on people and talent development and retention through effective recruitment, on-boarding, coaching, and training. Gives constructive, timely, and appropriate feedback to team members.

Works effectively with company attorneys and seeks legal advice on quality and regulatory issues as appropriate.

Supports the development and ongoing maintenance of the company’s business continuity plan.

Oversees the development, implementation, and maintenance of quality management systems (QMS) to ensure compliance with third-party certifying bodies, retailer requirements, and cGMP regulations applicable to dietary supplements, cosmetics, and other consumer health products.

Drives initiatives to improve product quality, operational efficiency, and customer satisfaction.

Oversees the creation and implementation of an Acceptable Quality Level (AQL) program to ensure consistent product quality and compliance with customer expectations.

Monitors and analyzes quality performance metrics, identifying areas for improvement and implementing corrective actions.

Oversees the Environmental, Health, and Safety (EHS) program to ensure a safe and compliant workplace, including the development and enforcement of EHS policies, procedures, training, and incident response plans.

Ensures compliance with all relevant regulatory requirements and standards in the markets in which we operate, including FDA, Health Canada, TGA, and in international growth markets.

Oversees the timely preparation and submission of regulatory filings, including product registrations, renewals, and amendments.

Oversees and is accountable for end-to-end product lifecycle quality and regulatory compliance, from new product development through end of shelf life.

Oversees the review and approval of product labeling, claims, substantiation, and marketing materials to ensure compliance with regulatory requirements.

Oversees the company’s product safety program, ensures compliance with adverse event reporting requirements, and ensures all dietary ingredients are supported by adequate safety data and are permissible for use per applicable regulatory requirements.

Oversees the development and implementation of policies and procedures to ensure Regulatory team effectiveness and ongoing compliance with regulatory requirements.

Monitors the external environment and stays abreast of regulatory developments affecting our products and business.

Builds and maintains strong relationships with regulatory agencies, industry associations, and other key stakeholders.

Champions a culture of continuous improvement within the Quality and Regulatory teams, encouraging the adoption of best practices and innovative solutions.

Leads change management initiatives to enhance overall quality and regulatory performance and operational excellence.

Collaborates with cross-functional teams to integrate quality and regulatory requirements into all relevant aspects of the business.

Defines and drives a culture of quality and compliance across all operations, ensuring these principles are embedded in the right processes and systems.

Supports the creation and maintenance of the company’s enterprise risk management program.

Actively identifies and mitigates quality and regulatory risks, ensuring robust risk management processes are in place across the Quality, EHS, and Regulatory functions.

Ensures effective investigations are conducted into any reported issues of non-compliance, and that corrective and preventative actions are documented and closed timely.

Develops and manages the Quality and Regulatory department budgets, ensuring efficient allocation of resources to meet objectives.

Monitors and controls expenditures to ensure cost-effective quality and regulatory operations while maintaining high standards.

Qualification

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Quality AssuranceRegulatory AffairsCGMP RegulationsQuality Management SystemsContinuous ImprovementProject ManagementBudget ManagementFDA ComplianceConsumer Healthcare ExperienceISO Standards

Required

Bachelor's degree in chemistry, microbiology, pharmacy, engineering, food science or related field is required; post graduate degree preferred

At least 15 years of experience working in quality assurance, regulatory affairs other relevant roles, demonstrating increasing management and leadership responsibility

Proven track record of leading quality or regulatory functions in a complex, FDA-regulated environment

Demonstrated ability to drive continuous improvement and foster a culture of compliance and quality excellence

Strong knowledge of industry standards and US cGMP and regulatory requirements (e.g., FDA, NSF, ISO)

Strong analytical, critical, and strategic thinking skills

Excellent oral and written communication and presentation skills; presents ideas clearly and convincingly to gain commitment

Excellent organizational skills and attention to detail

Strong project management skills

Displays strong interpersonal and communication skills, confidence, presence, and poise under pressure and otherwise

Works collaboratively in a cross-functional team environment

Is forward-thinking and takes initiative to identify and solve problems

Speaks up and has a point of view, is unwilling to accept the status quo as a response, and can respectfully challenge others and stand alone when necessary. Pushes back with courage and the appropriate level of respect and professionalism

Adapts easily to shifting priorities, is flexible and resilient and not rigid in thinking

Demonstrates commitment to a culture of compliance and quality excellence

Positively receives and incorporates constructive coaching and feedback

Has a positive attitude, is solution-oriented and tenacious in pursuit of company goals

Motivates others toward common goals

Maintains confidentiality of highly sensitive company information

Acts with integrity and accountability